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Remediation of Visual Perceptual Impairments in People With Schizophrenia (VRiS)

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UltimEyes
Contour Integration Training
UltimEyes + Contour Integration Training
MyBrainSolutions
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. SCID-5 diagnosis of schizophrenia;
  2. 18-60 years old;
  3. speaks English;
  4. able to complete the MATRICS Consensus Cognitive Battery (MCCB) at the baseline assessment (for R33);
  5. a raw score of 37 or greater on the Wide Range Achievement Test, Reading subtest (WRAT-3), to establish a minimum reading level (6th grade) and to estimate premorbid IQ; and
  6. clinically stable as indicated by no antipsychotic medication changes in the last month or if on depot, no change in the past 2 months.

Exclusion Criteria:

  1. history of intellectual disability, or developmental or neurological disorder;
  2. history of brain trauma associated with loss of consciousness for > 10 minutes or behavioral sequelae;
  3. alcohol or substance use disorder within the last 6 months; and
  4. history of eye disease (e.g., glaucoma, retinopathy).

Sites / Locations

  • University of Rochester Medical Center - Strong Ties Community Support Clinic
  • New York Presbyterian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Contrast sensitivity

Perceptual organization

Contrast sensitivity + Perceptual org.

Cognitive remediation

Arm Description

UltimEyes

Contour Integration Training

UltimEyes + Contour Integration Training

MyBrainSolutions

Outcomes

Primary Outcome Measures

Contrast sensitivity - behavioral
Peak contrast, as measures by a behavioral (psychophysical) measure of contrast sensitivity.
Contrast sensitivity - electrophysiological
Steady state visual evoked potential (ssVEP) amplitudes recorded during the contrast sensitivity task.
Contour integration
Total score on the Jittered-Orientation Visual Integration Task, or JOVI), a psychophysical measure of perceptual organization.

Secondary Outcome Measures

Reading speed
Minnesota Low-Vision Reading Test (MNREAD): This test assesses reading speed ability. The charts contain 19 English sentences (60 characters each) with print sizes ranging from 1.3 to -0.5 logMAR at a distance of 16 inches (0.41 meters).
Emotion recognition
Total score on the Penn Emotion Recognition Test, a computerized test of emotion recognition.
Cognition
Total score on the MATRICS Consensus Cognitive Battery
Community functioning
Total score on the UCSD Performance-Based Skills Assessment (UPSA), a test of the ability to perform various skills important in residential and community settings.

Full Information

First Posted
October 4, 2017
Last Updated
August 17, 2023
Sponsor
University of Rochester
Collaborators
New York University, Weill Medical College of Cornell University, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03314129
Brief Title
Remediation of Visual Perceptual Impairments in People With Schizophrenia
Acronym
VRiS
Official Title
Visual Remediation in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
New York University, Weill Medical College of Cornell University, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness of a visual remediation intervention for people with schizophrenia. The intervention targets two visual functions that much research has shown are impaired in many people with the disorder, namely contrast sensitivity and perceptual organization. The first phase of the study will test the effects of interventions targeting each of these processes, as well as the effects of a combined package. A control condition of higher-level cognitive remediation is included as a fourth condition. The second phase of the study will evaluate the effectiveness of the most effective intervention from the first phase, but in a new and larger sample of individuals. Outcome measures include multiple aspects of visual functioning, as well as visual cognition and overall community functioning.
Detailed Description
It is increasingly clear that people with schizophrenia have a range of visual perception impairments, including in low-level vision (e.g., acuity, contrast sensitivity) and mid-level vision (e.g., perceptual organization, coherent motion detection). These impairments are significantly related to poorer performance on cognitive (e.g., visual learning and memory) and social cognitive (e.g., facial emotion decoding) measures, and to worse functional outcomes. To date, there is no accepted technique for visual remediation for schizophrenia, and almost no work has been done in this area. However, visual remediation is a well-developed subfield within cognitive rehabilitation for traumatic brain injury (TBI) patients, and initial studies of short-term visual perceptual learning in schizophrenia indicate that plasticity exists that could support longer-term changes. Therefore, the overall goal of the proposed project is to test a visual remediation intervention for schizophrenia and determine its effects on specific visual targets with well-understood neurobiological mechanisms. The goal of the R61 is to determine the optimal intervention for improving the targets of contrast sensitivity (CS) and perceptual organization (PO). Extensive evidence exists for impaired CS and PO in schizophrenia. Moreover, these targets are prototypical examples of gain control and integration, respectively, which were identified by the NIMH-sponsored CNTRICS initiative as being the two core mechanisms involved in visual disturbances in the disorder. The investigators will examine two computer-based interventions. One, ULTIMEYES (UE), targets CS. The other, contour integration training (CIT), targets PO. The investigators will also examine the effects of combined treatment (UE&CIT). An active computer-based control treatment will be included. There will be 40 sessions, with assessments after every 10 sessions (N=20/group). The R61 Specific Aim is to evaluate the effects of UE and CIT on CS and PO targets, respectively, to determine if treatment effects meet a pre-specified effect-size criterion. Results of the R61 will be used to identify the treatment (UE, CIT, or UE&CIT) and duration (i.e., dose) that most effectively and efficiently improves the target(s). The goal of the R33 is to conduct an initial randomized controlled trial (RCT) of the optimal treatment identified in the R61. The R33 Specific Aims are to: 1) replicate and extend R61 results supporting visual target engagement in an adequately powered RCT (N=50/group); and 2) determine if visual target engagement is associated with improvements in cognition, social cognition, and functional capacity. If the R33 hypotheses are confirmed, results will inform the design of a later RCT to further explore mediators and moderators of treatment effects, and to move towards a precision medicine approach, wherein we determine which individuals are most likely to benefit from this intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Contrast sensitivity
Arm Type
Experimental
Arm Description
UltimEyes
Arm Title
Perceptual organization
Arm Type
Experimental
Arm Description
Contour Integration Training
Arm Title
Contrast sensitivity + Perceptual org.
Arm Type
Experimental
Arm Description
UltimEyes + Contour Integration Training
Arm Title
Cognitive remediation
Arm Type
Active Comparator
Arm Description
MyBrainSolutions
Intervention Type
Behavioral
Intervention Name(s)
UltimEyes
Intervention Description
A computer program developed to improve contrast sensitivity and visual acuity.
Intervention Type
Behavioral
Intervention Name(s)
Contour Integration Training
Intervention Description
A computerized program to improve contour integration (a form of perceptual organization).
Intervention Type
Behavioral
Intervention Name(s)
UltimEyes + Contour Integration Training
Intervention Description
The combination of UltimEyes and Contour Integration Training
Intervention Type
Behavioral
Intervention Name(s)
MyBrainSolutions
Intervention Description
A computer program consisting of exercises to improve cognition (attention, memory, planning) and to facilitate goal setting.
Primary Outcome Measure Information:
Title
Contrast sensitivity - behavioral
Description
Peak contrast, as measures by a behavioral (psychophysical) measure of contrast sensitivity.
Time Frame
Years 1-5
Title
Contrast sensitivity - electrophysiological
Description
Steady state visual evoked potential (ssVEP) amplitudes recorded during the contrast sensitivity task.
Time Frame
Years 1-5
Title
Contour integration
Description
Total score on the Jittered-Orientation Visual Integration Task, or JOVI), a psychophysical measure of perceptual organization.
Time Frame
Years 1-5
Secondary Outcome Measure Information:
Title
Reading speed
Description
Minnesota Low-Vision Reading Test (MNREAD): This test assesses reading speed ability. The charts contain 19 English sentences (60 characters each) with print sizes ranging from 1.3 to -0.5 logMAR at a distance of 16 inches (0.41 meters).
Time Frame
Years 3-5
Title
Emotion recognition
Description
Total score on the Penn Emotion Recognition Test, a computerized test of emotion recognition.
Time Frame
Years 3-5
Title
Cognition
Description
Total score on the MATRICS Consensus Cognitive Battery
Time Frame
Years 3-5
Title
Community functioning
Description
Total score on the UCSD Performance-Based Skills Assessment (UPSA), a test of the ability to perform various skills important in residential and community settings.
Time Frame
Years 3-5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: SCID-5 diagnosis of schizophrenia; 18-60 years old; speaks English; able to complete the MATRICS Consensus Cognitive Battery (MCCB) at the baseline assessment (for R33); a raw score of 37 or greater on the Wide Range Achievement Test, Reading subtest (WRAT-3), to establish a minimum reading level (6th grade) and to estimate premorbid IQ; and clinically stable as indicated by no antipsychotic medication changes in the last month or if on depot, no change in the past 2 months. Exclusion Criteria: history of intellectual disability, or developmental or neurological disorder; history of brain trauma associated with loss of consciousness for > 10 minutes or behavioral sequelae; alcohol or substance use disorder within the last 6 months; and history of eye disease (e.g., glaucoma, retinopathy).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven M Silverstein, Ph.D.
Phone
585-275-6742
Email
steven_silverstein@urmc.rochester.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Butler, Ph.D.
Phone
845-398-6537
Email
pam.butler@NKI.rfmh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M Silverstein, Ph.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center - Strong Ties Community Support Clinic
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
New York Presbyterian Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Ahmed, Ph.D.
Phone
914-997-5251
Email
aoa9001@med.cornell.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32789191
Citation
Silverstein SM, Seitz AR, Ahmed AO, Thompson JL, Zemon V, Gara M, Butler PD. Development and Evaluation of a Visual Remediation Intervention for People with Schizophrenia. J Psychiatr Brain Sci. 2020;5:e200017. doi: 10.20900/jpbs.20200017. Epub 2020 Jul 20.
Results Reference
background
PubMed Identifier
27547852
Citation
Butler PD, Thompson JL, Seitz AR, Deveau J, Silverstein SM. Visual perceptual remediation for individuals with schizophrenia: Rationale, method, and three case studies. Psychiatr Rehabil J. 2017 Mar;40(1):43-52. doi: 10.1037/prj0000212. Epub 2016 Aug 22.
Results Reference
result

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Remediation of Visual Perceptual Impairments in People With Schizophrenia

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